Active substance: Cell-associated live recombinant turkey herpesvirus

Territory / Distribution category: GB POM-V

Authorisation holder:  MSD Animal Health UK Limited

Link to GB SPC

Active substance: Salmonella enterica subsp. enterica

Territory / Distribution category:  GB POM-V

Authorisation holder: Laboratorios Calier, S.A.

Link to SPC

Active substance: Carprofen

Territory / Distribution category:  GB & NI POM-V

Authorisation holder: Alfasan Nederland B.V.

Link to GB SPC 

Link to NI SPC

Active substance: Mycoplasma bovis

Territory / Distribution category:  GB POM-V

Authorisation holder: Zoetis UK Limited

Link to SPC

Active substance: Fluralaner

Territory / Distribution category:  NI POM-V

Authorisation holder: MSD Animal Health UK Limited

SPC available from EU Union Product Database

Active substance: Tramadol hydrochloride

Territory / Distribution category:  NI POM-V

Authorisation holder: CP Pharma Handelsgesellschaft mbH

Link to SPC 20mg

Link to SPC 50mg

Link to SPC 80mg

Link to SPC 120mg

Active substance: Tramadol hydrochloride

Territory / Distribution category:  NI POM-V

Authorisation holder: Alfasan Nederland B.V.

Link to SPC 8mg

Link to SPC 20mg

Link to SPC 40mg

Link to SPC 80mg

Active substance: Tramadol hydrochloride

Territory / Distribution category:  NI POM-V

Authorisation holder: Alfasan Nederland B.V.

Link to SPC 20mg

Link to SPC 80mg 

Active substance: Oxytetracycline

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Eurovet Animal Health B.V.

Change category: Contraindications, Special warnings

Summary of change:  

Section 3.5 (NI) and 4.5 (GB): Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.

Section 3.7 (NI) and 4.7 (GB): The safety of the veterinary medicinal product has not been established in cattle and pigs during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.

Link to GB SPC

Link to NI SPC

Active substances: Fenbendazole

Territory / Distribution category:  GB & NI POM-V

Authorisation holder: Huvepharma NV

Change category: Withdrawal periods

Summary of change:  

Section 3.12 (NI) and 4.11 (GB): Withdrawal period (zero days) for pheasant eggs. 

Link to GB SPC

Link to NI SPC

Active substances: Florfenicol

Territory / Distribution category:  GB & NI POM-V

Authorisation holder: MSD Animal Health UK Limited 

Change category: Contraindications, Special warnings

Summary of change:  

Section 4.5: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of fetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.

Section 4.7: The safety of the veterinary medicinal product has not been established in cattle and sheep during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of fetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.’ 

Link to GB SPC

Link to NI SPC

Active substances: Imidacloprid; Permethrin (Cis:Trans 40:60)

Territory / Distribution category: GB & NI POM-V

Authorisation holder:  Elanco Europe Ltd

Change category: Contraindications, Special warnings

Summary of change: 

Section 4.5: Laboratory studies in rabbits and rats with the excipient N-Methylpyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant. Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product by women of childbearing age.

Link to GB SPC over 10kg up to 25kg

Link to NI SPC over 10kg up to 25kg

Link to GB SPC over 25kg up to 40kg

Link to NI SPC over 25kg up to 40kg

Link to GB SPC over 40kg up to 60kg

Link to NI SPC over 40kg up to 60kg

Active substances: Phenylpropanolamine; 

Territory / Distribution category: GB POM-V

Authorisation holder: Vetoquinol UK Ltd

Change category: Adverse reactions

Summary of change: 

Section 4.6: Sympathomimetics may produce very rarely a wide range of effects, most of which mimic the results of excessive stimulation of the sympathetic nervous system such as effects on heart rate (tachycardia) or effects on blood pressure (increased blood pressure), which can induce proteinuria.

Dizziness, decrease in appetite, arrhythmia, collapse, aggression, hyperactivity (including

restlessness), polydipsia, polyuria, ataxia, seizure and hypersensitivity may occur in very 

rare cases.

Liquid diarrhoea/loose stool, emesis and lethargy have been reported rarely.

Link to GB SPC

Active substances: Meloxicam

Territory / Distribution category:  NI POM-V

Authorisation holder:  Boehringer Ingelheim Vetmedica Gmbh

Change category: Target species use

Summary of change: 

Section 4.9: Dosage for cats; Post-operative pain and inflammation following surgical procedures: After initial treatment with Metacam solution for injection with a starting dosage of 0.2 mg/kg, continue treatment 24 hours later with Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight. The oral follow-up dose may be administered once daily (at 24-hour intervals) for up to four days.

NI SPC will be posted on EU Union Product Database when available

Active substances: Meloxicam

Territory / Distribution category:  NI POM-V

Authorisation holder:  Boehringer Ingelheim Vetmedica Gmbh

Change category: Target species use

Summary of change: 

Section 4.9: Reduction of post-operative pain and inflammation when administration of meloxicam is to be continued as an oral follow-up therapy: Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.1 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia. To continue treatment for up to five days, this initial dose may be followed 24 hours later by administration of Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight. The oral follow-up dose may be administered for up to a total of four doses at 24 hour intervals.

Reduction of post-operative pain and inflammation where no oral follow-up treatment is possible e.g. feral cats: Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.15 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia. In this case do not use oral follow up treatment.

NI SPC will be posted on EU Union Product Database when available

Active substances: Meloxicam

Territory / Distribution category:  NI POM-V

Authorisation holder:  Boehringer Ingelheim Vetmedica Gmbh

Change category: Target species use

Summary of change: 

Section 4.2: Indication for cats; Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.

Section 4.5i: For post-operative pain and inflammation following surgical procedures in cats: In case additional pain relief is required, multimodal pain therapy should be considered.

Section 4.9: Dosage for cats; Reduction of post-operative pain and inflammation when administration of meloxicam is to be continued as an oral follow-up therapy: Single subcutaneous injection at a dosage of 0.2 mg meloxicam/kg body weight (i.e. 0.04 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia. To continue treatment for up to five days, this initial dose may be followed 24 hours later by administration of Metacam 0.5 mg/ml oral suspension for cats at a dosage of 0.05 mg meloxicam/kg body weight. The oral follow-up dose may be administered for up to a total of four doses at 24 hours intervals.  Reduction of post-operative pain and inflammation where no oral follow-up treatment is possible e.g. feral cats: Single subcutaneous injection at a dosage of 0.3 mg meloxicam/kg body weight (i.e. 0.06 ml/kg body weight) before surgery, for example at the time of induction of anaesthesia.  In this case do not use oral follow up treatment.

NI SPC will be posted on EU Union Product Database when available

Active substance: Meloxicam

Territory / Distribution category: GB & NI POM-V

Authorisation holder:  EU Pharmaceuticals Ltd

Link to GB SPC

Link to NI SPC

Active substance: Meloxicam

Territory / Distribution category:  GB & NI POM-V

Authorisation holder: EU Pharmaceuticals Ltd

Link to GB SPC

Link to NI SPC

Active substance: Medetomidine Hydrochloride

Territory / Distribution category:  GB POM-V

Authorisation holder: Alfasan Nederland B.V.

Link to SPC 

Active substance: Thiamazole

Territory / Distribution category:  GB POM-V

Authorisation holder: Dechra Limited

Link to SPC

Active substance:  Porcine circovirus-2

Territory / Distribution category: NI POM-V

Authorisation holder: Ceva-Phylaxia Veterinary Biologicals Co. Ltd

Change category:  Target Species use; Interactions and Overdose

Summary of change:  

Section 4.2: Duration of immunity (DOI) amended to 23 weeks.

Section 4.8: Duration of lethargy amended to 1-2 days and to include warning when Circovac is used mixed with Hyogen.

Link to SPC to follow

Active substances:  Clostridium novyi, Clostridium perfringens, Escherichia coli

Territory / Distribution category:  GB & NI POM-V

Authorisation holder: Laboratorios Hipra SA

Change category: Target species use; Interactions and overdose

Summary of change:  

Sections 4.8, 4.9 and 6.5: Amended to include the associated use of the vaccine Suiseng Diff/A with the vaccine Suiseng Coli/C.

Link to GB SPC

Link to NI SPC

Active substances: Imidacloprid; Permethrin (Cis:Trans 40:60)

Territory / Distribution category: GB & NI POM-V

Authorisation holder:  Elanco Europe Ltd

Change category:  Contraindications; Special warnings

Summary of change: 

Section 4.5: Laboratory studies in rabbits and rats with the excipient N-Methylpyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant. Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product by women of childbearing age.

Link to GB SPC over 10kg up to 25kg

Link to NI SPC over 10kg up to 25kg

Link to GB SPC over 25kg up to 40kg

Link to NI SPC over 25kg up to 40kg

Link to GB SPC over 40kg up to 60kg

Link to NI SPC over 40kg up to 60kg

Active substances: Bordetella bronchiseptica

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Zoetis UK Limited

Change category: Target species use

Summary of change: 

Section 4.2: Amendment of the onset of immunity (OOI) to 7 days.

Link to GB SPC

Link to NI SPC

Active substances: Meloxicam

Territory / Distribution category: NI POM-V

Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh 

Change category: Target species use

Summary of change: 

Section 4.2: Indication for cats; Alleviation of mild to moderate post-operative pain and inflammation following surgical procedures in cats, e.g. orthopaedic and soft tissue surgery.

Active substance: Marek's disease virus

Territory / Distribution category: NI POM-V

Authorisation holder:  Boehringer Ingelheim Vetmedica GmbH

Link to SPC to follow

Active substance: Meloxicam

Territory / Distribution category:  GB & NI POM-V

Authorisation holder: Huvepharma N.V.

Link to GB SPC

Link to NI SPC

Active substance: Pyrantel, Sarolaner, Moxidectin

Territory / Distribution category:  GB POM-V

Authorisation holder: Zoetis UK Limited

Link to SPC 1.25 - 2.5kg

Link to SPC 2.5 - 5kg

Link to SPC 5 - 10kg

Link to SPC 10 - 20kg

Link to SPC 20 - 40kg

Link to SPC 40 - 60kg

Active substance: Dexmedetomidine hydrochloride

Territory / Distribution category:  GB & NI POM-V

Authorisation holder: Alfasan Nederland B.V.

Link to NI SPC

Link to GB SPC

Active substance: Imidacloprid, Moxidectin

Territory / Distribution category:  GB & NI POM-V

Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd

Link to GB SPC

Link to NI SPC

Active substance: Imidacloprid, Moxidectin

Territory / Distribution category:  GB & NI POM-V

Authorisation holder:Chanelle Pharmaceuticals Manufacturing Ltd

Link to GB SPC

Link to NI SPC

Active substance: Thiamazole

Territory / Distribution category:  GB & NI POM-V

Authorisation holder: Ecuphar NV

Link to GB SPC

Link to NI SPC

Active substance: Ivermectin

Territory / Distribution category: GB POM-VPS

Authorisation holder: Chanelle Animal Health Ltd

Change category:  Target species use

Summary of change:  

Section 4.2: Sheep added as a new target species for the indication of treatment of infections with a number of specific gastrointestinal roundworms, lungworms, nasal bots (Oestrus ovis) and mange mites (Psoroptes ovis).  Multiple associated changes have been made to sections of the SPC.

Link to GB SPC

Active substance: Porcine circovirus-2

Territory / Distribution category:  GB POM-V

Authorisation holder: Ceva Animal Health Ltd

Change category: Interactions and Overdose

Summary of change:  

Section 4.8. Harmonisation of the duration of immunity for Circovac between its single use and associate mixed use with Hyogen to 23 weeks.

Link to GB SPC

Active substance: Florfenicol

Territory / Distribution category:  GB & NI POM-V

Authorisation holder: Laboratorios Calier, S.A.

Change category: Contraindications, Special warnings

Summary of change: 

Section 3.5 (NI) / 4.5 (GB): Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.

Section 3.7 (NI) / 4.7 (GB): The safety of the veterinary medicinal product has not been established in cattle and pigs during pregnancy, lactation, or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.

Section 5.5 (NI) / 6.6 (GB): The veterinary medicinal product should not enter water courses as florfenicol may be dangerous for fish and other aquatic organisms.

Link to GB SPC

Link to NI SPC

Active substance: Fenbendazole

Territory / Distribution category:  GB & NI  POM-V

Authorisation holder: Huvepharma N.V.

Change category: Target species use

Summary of change: 

Section 4.2 ( GB) 3.2 (NI): Added the treatment of chickens infected with adult stages of Raillietina echinobothrida. Multiple associated changes have been made to sections of the SPC.

Link to GB SPC

Link to NI SPC

Active substance: Florfenicol

Territory / Distribution category:  GB & NI POM-V

Authorisation holder: Vetpharma Animal Health, S.L

Change category: Contraindications, Special warnings

Summary of change: 

Section 4.5: Updated to reflect that laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal products with serious caution to avoid accidental self-injection.

Section 4.7: Updated to reflect that the safety of the veterinary medicinal products has not been established in the target species during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects.

Link to GB SPC

Link to NI SPC

Active substance:  Oxytetracycline

Territory / Distribution category:  UK POM-V

Authorisation holder: Bimeda Animal Health Limited

Change category: Contraindications, Special warnings

Summary of change: 

Section 4.5: Updated to reflect that laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal products with serious caution to avoid accidental self-injection.

Section 4.7: Updated to reflect that the safety of the veterinary medicinal products has not been established in the target species during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects.

Link to UK SPC

Active substance: Infectious bronchitis virus

Territory / Distribution category:  GB POM-V

Authorisation holder: MSD Animal Health UK Limited

Change category: Target species use

Summary of change: 

Section 4.2: To include the onset and duration of immunity.  Onset of immunity: 3 weeks and Duration of immunity: at least 6 weeks. 

Link to GB SPC

Active substance: Moxidectin

Territory / Distribution category:  UK POM-VPS

Authorisation holder: Zoetis UK Limited

Change category: 

Summary of change: 

Additional statements were added throughout the SPC in relation to the development of resistance.

Link to SPC

Active substance: Toltrazuril

Territory / Distribution category:  GB & NI POM-V

Authorisation holder: Vetpharma Animal Health, S.L

Change category: Withdrawal period

Summary of change: 

Section 4.11: Updated to reflect that the veterinary medicinal product must not be used within 6 weeks before the start of the laying period.

Link to GB SPC

Link to NI SPC

Active substance: Leptospira interrogans serogroup Canicola, Leptospira interrogans serogroup Icterohaemorrhagiae, Leptospira interrogans serogroup Australis, Leptospira kirschneri serogroup Grippotyphosa

Territory / Distribution category: NI POM-V

Authorisation holder:  Intervet International BV

Link to SPC to follow

Active substance: Velagliflozin

Territory / Distribution category:  NI POM-V

Authorisation holder: Boehringer Ingelheim Vetmedica GmbH

Link to SPC to follow

Active substance: Moxidectin

Territory / Distribution category: GB & NI POM-VPS

Authorisation holder: Zoetis UK Limited     

Change category:  Contraindications, Special warnings; Target species use

Summary of change:  

Section 4.4: Updated to reflect current antimicrobial resistance data. 

Section 4.9: Underdosing could result in ineffective use and may favour resistance development.  If animals are to be treated collectively, reasonably homogeneous groups should be set up, and all animals of a group should be dosed at the rate corresponding to the heaviest one. 

Section 5.1: Resistance to moxidectin is mediated in part by membrane transporter P-glycoproteins, and cross resistance with other macrocyclic lactones is possible. 

Link to GB SPC

Link to NI SPC

Active substance: Moxidectin

Praziquantel

Territory / Distribution category:  GB & NI POM-VPS

Authorisation holder: Zoetis UK Limited

Change category: Adverse reactions

Summary of change:  

Section 4.6: Digestive discomfort (colic, loose stool) has been observed in very rare cases based on post-marketing surveillance data.

Link to GB SPC

Link to NI SPC

Active substance:  Equine influenza virus

Territory / Distribution category:  GB  POM-V

Authorisation holder: MSD Animal Health UK Limited

Change category: Adverse reactions

Summary of change: 

Section 4.6: Added Hypersensitivity reaction.

Link to GB SPC

Active substance: Sulfamethoxazole

Trimethoprim

Territory / Distribution category:  GB & NI  POM-V

Authorisation holder: Eurovet Animal Health B.V.       

Change category: Contraindications, Special warnings

Summary of change: 

Section 4.5: Laboratory studies in rabbits and rats conducted with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant. Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product by women of childbearing age.

Section 4.7: The safety of the veterinary medicinal product has not been established in pigs and chickens during pregnancy, lactation, lay or in animals intended for breeding.  Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. 

Link to GB SPC

Link to NI SPC

Active substance:  Bismuth Subnitrate

Territory / Distribution category:  GB & NI POM-V

Authorisation holder: Norbrook Laboratories Limited

Change category: Adverse reactions; Contraindications, Special warnings; Target species use.

Summary of change: 

Section 4.6: Acute mastitis has been reported very rarely after use of this product, primarily due to the poor infusion technique and lack of hygiene. 

Refer to sections 4.5 and 4.9 regarding the importance of aseptic technique.

Link to GB SPC

Link to NI SPC

Active substance:  Clenbuterol Hydrochloride

Territory / Distribution category:  GB POM-V

Authorisation holder: Floris Animal Health Limited 

Change category: Adverse reactions; Contraindications, Special warnings

Summary of change: 

Section 4.6: Updated to include lethargy as an adverse event of rare frequency. 

Section 4.7: If used during pregnancy, treatment must be discontinued a minimum of 4 days before the expected time of delivery or at signs of approaching parturition, since uterine contractions may be abolished or labour may be prolonged.

Link to GB SPC

Active substances: Canine adenovirus; Canine distemper virus; Canine parainfluenza virus; Canine parvovirus

Territory / Distribution category: GB & NI  POM-V

Authorisation holder:  Virbac

Change category:  Interactions

Summary of change: 

Section 4.8: Vaccine can be mixed and administered with Virbac’s Leptospira vaccine containing the serovars Leptospira interrogans (serogroup Canicola serovar Canicola and serogroup Icterohaemorrhagiae serovar Icterohaemorrhagiae) or Virbac’s rabies vaccine, if available.

Link to GB SPC

Link to NI SPC

Active substances: Frunevetmab

Territory / Distribution category: GB & NI POM-V

Authorisation holder:  Zoetis UK Limited

Change category:  Adverse reactions

Summary of change: 

GB Section 4.6: Added anaphylaxis with frequency very rare

NI SPC: Adverse Reactions: skin disorders (e.g. skin scab, skin sore) now categorised as rare.

Link to GB SPC

Link to NI SPC to follow

Active substance: Cryptosporidium parvum

Territory / Distribution category: NI POM-V

Authorisation holder:  Intervet International BV

Link to SPC to follow

Active substance: Salmonella typhimurium

Territory / Distribution category:  GB POM-V

Authorisation holder: Laboratorios Calier, SA

Link to GB SPC

Active substance: Meloxicam

Territory / Distribution category:  NI  POM-V

Authorisation holder:  Zoetis UK Limited

Link to SPC 1mg to follow

Link to SPC 2.5mg to follow

Active substance: Meloxicam

Territory / Distribution category: NI POM-V 

Authorisation holder: Dechra Regulatory B.V.

Link to 1.0mg SPC to follow

Link to 2.5mg SPC to follow

Link to 4.0mg SPC to follow

Active substance: Milbemycin Oxime (A3 and A4), Praziquantel

Territory / Distribution category: GB & NI  POM-V

Authorisation holder: Ceva Animal Health Ltd

Link to GB SPC

Link to NI SPC

Active substance: Milbemycin Oxime (A3 and A4), Praziquantel

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Ceva Animal Health Ltd

Link to GB SPC

Link to NI SPC

Active substance: Milbemycin Oxime (A3 and A4), Praziquantel

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Ceva Animal Health Ltd

Link to GB SPC

Link to NI SPC

Active substance: Milbemycin Oxime (A3 and A4), Praziquantel

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Ceva Animal Health Ltd

Link to GB SPC

Link to NI SPC

Active substance: Hemoglobin betafumaril (bovine) 

Territory / Distribution category: GB & NI POM-V

Authorisation holder: New Alpha Innovation Biopharmaceutical Ireland Limited

Link to GB SPC

Link to NI SPC to follow

Active substance: Deltamethrin 10 mg/ml

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Pharmaq AS     

Change category:  Contraindications, Special warnings

Summary of change:  

Section 4.5:  Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects.  The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant.  Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product by women of childbearing age.

Section 4.7: The safety of the veterinary medicinal product has not been established in Atlantic salmon and rainbow trout intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.

Link to GB SPC

Link to NI SPC

Active substance: Ivermectin 10 mg

Territory / Distribution category: NI POM-VPS

Authorisation holder: Chanelle Animal Health Ltd     

Change category: Target Species Use 

Summary of change:  

Section 4.1, 4.2 and various: Addition of sheep as a target species.  Treatment of infections with a number of specific gastrointestinal roundworms, lungworms, nasal bots (Oestrus ovis) and mange mites (Psoroptes ovis) in sheep.

Link to NI SPC

Active substance:  Porcine circovirus-2

Territory / Distribution category:  NI  POM-V

Authorisation holder: Zoetis Belgium

Change category: Target Species Use

Summary of change: 

Section 4.9: Added option of administering CircoMax and CircoMax Myco intramuscularly, using needle-free devices. 

Link to SPC to follow

Active substance:  Eprinomectin

Territory / Distribution category:  GB & NI  POM-V

Authorisation holder: Ceva Animal Health Ltd        

Change category: Target Species Use

Summary of change: 

Section 4.2: Indicated for the treatment of infestations of nasal bots (Oestrus ovis) in sheep and goats.

Link to GB SPC

Link to NI SPC

Active substance: Clostridium tetani

Territory / Distribution category:  GB POM-V

Authorisation holder: MSD Animal Health UK Limited   

Change category: Adverse reactions

Summary of change: 

Section 4.6: Addition of the adverse event hypersensitivity reaction with a very rare frequency

Link to GB SPC

Active substance:  Porcine circovirus-2

Territory / Distribution category:  NI POM-V

Authorisation holder: Intervet International BV 

Change category: Target Species Use

Summary of change: 

Section 4.2: Duration of immunity 26 weeks.

Link to NI SPC to follow

Active substance: West Nile virus

Territory / Distribution category: GB POM-V  

Authorisation holder:  Boehringer Ingelheim Vetmedica Gmbh    

Change category: Adverse reastions; Target Species Use

Summary of change: 

Section 4.6:  Addition of injection site abscess with a very rare frequency. 

Section 4.9: For the administration of the vaccine, use sterile and antiseptic-free and/or disinfectant-free material.

Link to GB SPC

Active substance:  Infectious bovine rhinotraceitis virus

Territory / Distribution category: NI POM-V

Authorisation holder:  Zoetis UK Limited    

Change category: Target Use Species

Summary of change: 

Section 3.9: Added the intranasal vaccination route to cattle of 3 months of age and above.

Link to NI SPC

Active substances: Imidacloprid, Permethrin (Cis:Trans 40:60)

Territory / Distribution category: GB   POM-V

Authorisation holder:  KRKA, d.d., Novo mesto   

Change category:  Contraindications, Special warnings

Summary of change: 

Section 4.7: The safety of the veterinary medicinal product has not been established in dogs during pregnancy, lactation or in animals intended for breeding.  Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects.  Use only according to the benefit-risk assessment by the responsible veterinarian.

Link to GB SPC

Active substances: Imidacloprid, Permethrin (Cis:Trans 40:60)

Territory / Distribution category: GB   POM-V

Authorisation holder:  KRKA, d.d., Novo mesto   

Change category:  Contraindications, Special warnings

Summary of change: 

Section 4.7: The safety of the veterinary medicinal product has not been established in dogs during pregnancy, lactation or in animals intended for breeding.  Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects.  Use only according to the benefit-risk assessment by the responsible veterinarian.

Link to GB SPC

Active substances: Imidacloprid, Permethrin (Cis:Trans 40:60)

Territory / Distribution category: GB   POM-V

Authorisation holder:  KRKA, d.d., Novo mesto 

Change category:  Contraindications, Special warnings

Summary of change: 

Section 4.7: The safety of the veterinary medicinal product has not been established in dogs during pregnancy, lactation or in animals intended for breeding.  Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects.  Use only according to the benefit-risk assessment by the responsible veterinarian.

Link to GB SPC

Active substances: Imidacloprid, Permethrin (Cis:Trans 40:60)

Territory / Distribution category: GB   POM-V

Authorisation holder:  KRKA, d.d., Novo mesto 

Change category:  Contraindications, Special warnings

Summary of change: 

Section 4.5: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant. Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product by women of childbearing age.

Section 4.7: The safety of the veterinary medicinal product has not been established in dogs during pregnancy, lactation or in animals intended for breeding.  Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects.  Use only according to the benefit-risk assessment by the responsible veterinarian.

Link to GB SPC

Active substance: Maropitant

Territory / Distribution category: GB POM-V

Authorisation holder: Dechra Regulatory B.V.  

Change category: Adverse reactions

Summary of change:

Section 4.6: Added lethargy, ataxia, convulsion, seizures, and muscle tremors as very rare adverse events.

Link to GB SPC

Active substance: Praziquantel

Pyrantel Embonate

Territory / Distribution category: GB & NI    NFA-VPS

Authorisation holder: Chanelle Pharmaceuticals Manufacturing Ltd     

Change category: Adverse reactions

Summary of change:

Section 4.6: Added hypersalivation as a very rare adverse event.

Link to GB SPC

Link to NI SPC

Active substance: Trimethoprim, Sulfadiazine Sodium

Territory / Distribution category: NI POM-V

Authorisation holder:  Huvepharma NV

Link to SPC

Active substance: Cloprostenol

Territory / Distribution category:  GB & NI POM-V

Authorisation holder: Syn Vet-Pharma Ireland Limited

Link to GB SPC

Link to NI SPC

Active substance: Mycoplasma bovis

Territory / Distribution category:  NI  POM-V

Authorisation holder:  Zoetis UK Limited

Link to SPC

Active substance: Maropitant

Territory / Distribution category: GB & NI POM-V 

Authorisation holder: KRKA, d.d., Novo mesto

Link to GB SPC

Link to NI SPC

Active substance: Thiamazole

Territory / Distribution category: NI  POM-V

Authorisation holder: Dechra Limited

Link to SPC

Active substance: Lotilaner

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco GmbH

Link to SPC

Active substance: Lotilaner

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco GmbH

Link to SPC

Active substance: Lotilaner

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco GmbH

Link to SPC

Active substance: Lotilaner

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco GmbH

Link to SPC

Active substance: Lotilaner

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco GmbH

Link to SPC

Active substance: Lotilaner

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco GmbH

Link to SPC

Active substance: Lotilaner

Territory / Distribution category: GB POM-V

Authorisation holder: Elanco GmbH

Link to SPC

Active substance: Milbemycin Oxime (A3 and A4), Praziquantel

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Ceva Animal Health Ltd

Link to GB SPC

Link to NI SPC

Active substance: Meloxicam

Territory / Distribution category: GB & NI POM-V

Authorisation holder: EU Pharmaceuticals Ltd

Link to GB SPC

Link to NI SPC

Active substance: Meloxicam

Territory / Distribution category: GB & NI POM-V

Authorisation holder: EU Pharmaceuticals Ltd

Link to GB SPC

Link to NI SPC

Active substance: Trilostane

Territory / Distribution category: NI POM-V

Authorisation holder: CP Pharma Handelsgesellschaft mbH

Link to SPC 10mg

Link to SPC 30mg

Link to SPC 60mg

Link to SPC 120mg

Link to SPC 150mg

Active substance: Phenylpropanolamine Hydrochloride

Territory / Distribution category: GB & NI POM-V

Authorisation holder: Alfasan Nederland B.V.

Link to GB SPC

Link to NI SPC

Active substance: Florfenicol, Flunixin

Territory / Distribution category: GB & NI

Authorisation holder: MSD Animal Health UK Limited

Change category:  Contraindications, Special warnings

Summary of change:  

Section 4.5i GB SPC/3.5i NI SPC: Flunixin is toxic to avian scavengers. Do not administer to animals susceptible to enter wild fauna food chain. In case of death or sacrifice of treated animals, ensure that they are not made available to wild fauna. 

People with known hypersensitivity to propylene glycol and polyethylene glycols should avoid contact with the veterinary medicinal product. 

Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.

Section 4.7 GB SPC/3.7 NI SPC: The safety of the veterinary medicinal product has not been established in cattle during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects.

Use only according to the benefit-risk assessment by the responsible veterinarian.

Link to GB SPC

Link to NI SPC

Active substance: Florfenicol

Territory / Distribution category: UK  POM-V

Authorisation holder: Laboratorios Hipra SA

Change category: Contraindications, Special warnings

Summary of change:  

Section 4.5ii: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.

Section 4.7: The safety of the veterinary medicinal product has not been established in cattle and swine during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.

Link to SPC

Active substance: Florfenicol

Territory / Distribution category:  UK  POM-V

Authorisation holder: Kela NV

Change category: Contraindications, Special warnings

Summary of change: 

Section 4.5ii: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.

Section 4.7: The safety of the veterinary medicinal product has not been established in cattle and pigs during pregnancy and lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects.  Use only according to the benefit/risk assessment by the responsible veterinarian.

Link to SPC

Active substances: Meloxicam

Territory / Distribution category:  UK  POM-V

Authorisation holder:  AniMedica GmbH 

Change category:  Contraindications, Special warnings

Summary of change: 

Section 4.5ii: NSAIDs and other prostaglandin inhibitors are known to have adverse effects on pregnancy and/or embryofoetal development.  Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects.  Women of childbearing age, pregnant women or women suspected of being pregnant should use the veterinary medicinal product with serious caution to avoid accidental self-injection.

Section 4.7: Do not use in pregnant or lactating animals.  The safety of the veterinary medicinal product has not been established in dogs and cats during pregnancy, lactation or in animals intended for breeding. Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.

Link to SPC

Active substances: Marbofloxacin

Territory / Distribution category: UK  POM-V

Authorisation holder: Vetoquinol UK Ltd

Change category: Contraindications, Special warnings

Summary of change: 

Section 4.3: Do not use in cases of resistance to other fluoroquinolones (cross-resistance).’ And ‘Do not use in cases of hypersensitivity to the active substance, to any other quinolones or to any of the excipients.

Section 4.5i: Fluoroquinolones have been shown to induce erosion of articular cartilage in juvenile dogs and care should be taken to dose accurately especially in young animals.

Fluoroquinolones are also known for their potential neurological side effects. Cautious use is recommended in dogs and cats diagnosed as suffering from epilepsy.

Additional precautions have been added relating to prudent use of fluoroquinolones.

Section 4.6: Very rarely, hypersensitivity reactions, diarrhoea and vomiting have been reported.  The frequency of adverse reactions is defined using the following convention: very rare (less than 1 animal in 10,000 animals treated, including isolated reports).

Link to SPC

Active substance: Afoxolaner

Milbemycin Oxime (A3 and A4)

Territory / Distribution category: NI  POM-V

Authorisation holder: Boehringer Ingelheim Vetmedica Gmbh

Change category:  Target species use

Summary of change: 

Reduction in minimum bodyweight of animals to which Nexgard Spectra 9 mg/2 mg chewable tablets may be administered, from 2 kg to 1.35 kg (maximum bodyweight limit for this tablet strength remains as 3.5 kg).  In the absence of available data, treatment of puppies less than 8 weeks of age and dogs less than 1.35 kg bodyweight with Nexgard Spectra chewable tablets should be based on a benefit-risk assessment by the responsible veterinarian.

Link to SPC to follow

Active substance: Frunevetmab

Territory / Distribution category: NI POM-V

Authorisation holder: Zoetis Belgium

Change category: Adverse reactions

Summary of change:

Section 4.6: Addition of anaphylaxis as a very rare adverse event (<1 animal/10,000 animals treated, including isolated reports).  In case of such reactions, appropriate symptomatic treatment should be administered.

Link to SPC to follow

Active substance: Dinotefuran, Permethrin (Cis:Trans 40:60), Pyriproxyfen

Territory / Distribution category: GB  NFA-VPS

Authorisation holder: Ceva Animal Health Ltd

Change category:  Modification of user safety warning

Summary of change:

Section 4.5ii: Modification of an existing user safety warning to read as follows: ‘Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. The veterinary medicinal product should not be administered by pregnant women and women suspected of being pregnant.

Personal protective equipment consisting of gloves should be worn when handling the veterinary medicinal product by women of childbearing age.

Section 4.5i: Laboratory studies in rabbits and rats with the excipient N-methyl pyrrolidone have shown evidence of foetotoxic effects. Use only according to the benefit-risk assessment by the responsible veterinarian.

Link to SPC 1.5 - 4kg

Link to SPC 4 - 10kg

Link to SPC 10 - 25kg

Link to SPC 25 - 40kg

Link to SPC >40kg